Recall Z-1523-2015— Zimmer Gmbh
Class II · Terminated
Class II FDA medical device recall by Zimmer Gmbh, initiated 2015-03-18, terminated 2015-09-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.. Reason: Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery..
- Recalling firm
- Zimmer Gmbh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-18
- Terminated
- 2015-09-23
- Firm location
- Winterthur, Switzerland
Product description
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Reason for recall
Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.